Non-Hematologic Toxicity Sample Clauses

Non-Hematologic Toxicity. If grade 3 or 4 non-hematologic toxicity occurs: ● Delay treatment with all drugs ● Make an assessment regarding which drug or drugs produced the toxicity ● Reevaluate the patient at least once weekly until the toxicity resolves to ≤ grade 1 ● Reduce the dose of the offending agent or agents by one dose level ● If toxicity is irreversible or has not resolved to ≤ grade 1 after a 3-week treatment delay, the patient should be removed from the study ● Creatinine clearance (Cockcroft and Gxxxx formula) should be ≥45 mL/min prior to the start of any cycle.

Non-Hematologic Toxicity. The non-hematologic toxicity attributed to LB-100 should be managed as outlined in Table 6.4.2. Table 6.4.2 Dose adjustments of LB-100 Toxicity Management Dose Reduction Injection Site Reaction, grade 3 1.) Interrupt LB-100 2.) Administer topical treatment as necessary Reduce 1 dose level Grade 2 Nephrotoxicity 1.) Interrupt LB-100 2.) Reexamine patient at least weekly until toxicity improved to ≤ grade 1 Prolong infusion time to 2 hours. Grade 3 or 4 Nephrotoxicity 1.) Interrupt LB-100 2.) Reexamine patient at least weekly until toxicity improved to ≤ grade 1 Reduce 1 dose level and prolong infusion time to 2 hours. Other Grade 2 clinically significant non-hematologic toxicity* 1.) Interrupt LB-100 2.) Reexamine patient at least weekly until toxicity improved to ≤ grade 1 First occurrence: Maintain Dose Second occurrence: Reduce 1 dose level Other Grade 3-4 clinically significant non-hematologic toxicity* 1.) Interrupt LB-100 2.) Reexamine patient at least weekly until toxicity improved to ≤ grade 1 Reduce 1 dose level Any toxicity requiring a hold of atezolizumab 1.) Interrupt LB-100 2.) Reexamine patient at least weekly until atezolizumab can be restarted Maintain dose level. *Alopecia, and clinically insignificant lab abnormalities are examples of things that would not be considered clinically significant